· Hair Removal with Dynamic (DHR) and Fast Dynamic (FDHR) mode intended for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regime.

· Treatment of Pseudofolliculitis barbae (PFB).
· Use on all skin types (Fitzpatrick I-VI)

Device Description

The Eneka Pro is a non-invasive diode laser based system used for Hair Removal. The system is based on a single wavelength diode laser with 2 handpieces (spot sizes 20x9mm and 34x14mm) and the ability to control the pulse width, frequency and power. The Hair Removal Laser is intended for use on all skin types (Fitzpatrick skin types I-VI).

AI/ML Overview

The provided text is a 510(k) summary for the Eneka Pro device. It describes the device, its indications for use, and its substantial equivalence to a predicate device (Primelase). However, it explicitly states "No clinical studies were conducted as part of this submission" and does not include performance data or acceptance criteria that would typically be found in a clinical study report.

Therefore, most of the requested information regarding acceptance criteria, device performance, sample size, ground truth, experts, and adjudication methods is not available in the provided document.

Here's the information that can be extracted or derived from the text:

A table of acceptance criteria and the reported device performance
- Not available. The document does not provide a table with specific acceptance criteria or quantitative performance metrics from a study. It only lists general "Performance Testing" which included electrical safety, EMC, laser safety, biocompatibility, and software V&V.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not available. Since "No clinical studies were conducted," there is no test set of patients or associated provenance information.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not available. Without clinical studies, there was no need for experts to establish ground truth for a test set.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not available. Not applicable as no clinical studies were performed.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not available. This device is a laser hair removal system, not an AI-assisted diagnostic tool. No MRMC study was conducted.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a hardware device, not an algorithm, so "standalone" performance in the AI context does not apply.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not available. No clinical studies, therefore no ground truth was established from patient data. The "Performance Testing" mentioned refers to engineering and safety standards, not clinical outcomes.
The sample size for the training set
- Not applicable / Not available. This is a physical device, not a machine learning model, so there is no concept of a "training set" in the context of an algorithm.
How the ground truth for the training set was established
- Not applicable / Not available. As above, no training set for an algorithm was used.

Summary of available information regarding performance:

The document states: "Verification and validation activities were successfully completed and establish that the Eneka Pro performs as intended." These activities included:

IEC 60601-1:2005 (Third Edition) + A1:2012 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2:2014 Medical electrical equipment, Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility Requirements and tests
IEC 60601-2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
ISO 10993-1: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
Software verification and validation testing in accordance with FDA's Guidance for Premarket Submissions for Software Contained in Medical Devices.

The conclusion is based on substantial equivalence to the predicate device (Primelase) and the successful completion of these non-clinical performance and safety tests, rather than clinical efficacy data.

Summary

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February 10, 2023

TermoSalud % Connie Hoy Regulatory Consultant Hoy and Associates Regulatory Consulting 1830 Bonnie Way Sacramento, California 95825

Re: K223680

Trade/Device Name: Eneka Pro Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: Class II Product Code: GEX Dated: December 8, 2022 Received: December 8, 2022

Dear Connie Hoy:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Jianting Wang -S

Jianting Wang Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K223680

Device Name Eneka Pro

Indications for Use (Describe)

Indications for use for Eneka Pro diode laser hair removal system with 808nm applicators include:

· Treatment of Pseudofolliculitis barbae (PFB).
· Use on all skin types (Fitzpatrick I-VI)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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K223680

510(K) Summary Eneka Pro

This 510(K) Summary of safety and effectiveness for the Eneka Pro is submitted in accordance with the requirements of the SMDA 1990 and following guidance concerning the organization and content of a 510(K) summary.

Applicant	TermoSalud
Address	Ataulfo Friera Tarfe, 8 -33211 Gijón, Spain
Contact Person	Connie Hoy, Regulatory Consultant
Contact Information	conniehoy@hoyregulatory.com(530) 908-4903
Preparation Date	December 8, 2022
Device Trade Name	Eneka Pro
Common Name	Powered Laser Surgical Instrument
Regulation Number	21 CFR 878.4810
Product Code	GEX
Regulatory Class	II
Legally Marketed PredicateDevice	Primelase (K191321)

Device Description:

Indications for use:

Indications for use for Eneka Pro diode laser hair removal system with 808nm applicators include:

. Hair Removal with Dynamic (DHR) and Fast Dynamic (FDHR) modes intended for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
Treatment of Pseudofolliculitis barbae (PFB).
Use on all skin types (Fitzpatrick I-VI)

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510(K) Summary Eneka Pro

Substantial Equivalence—Technological Characteristics:

Specification	Subject Device	Predicate Device	Comparison
Principle of	AlGaAs Laser diode	AlGaAs Laser diode	Same
operation	array	array
Laser Wavelength	808nm	755 nm,810 nm,810 - 1060 nm	Same. Thissubmission includes 2handpieces with808nm wavelength,whereas the predicatehas additionalhandpieces with otherwavelengths. Theindications for use inthis submission areonly for those withthe Predicate's 810nmhandpiece
Laser Contact	Sapphire, AL203	Sapphire, AL203	Same
Spot Sizes	20x9mm (1.8cm2),34x14mm (4.75cm2)	20x9, 30x9, 30x17	1 same, 1 different.The spot size for theEneka Pro XLhandpiece is identicalto the predicate. Thedimension of the 2XLhandpiece is nearlyidentical to thepredicate. Thedimension veryslightly, but the totalarea is within .5cm ofthe predicate.
Fluence	40J/cm2	80 J/cm2	Different. Though thefluence of thepredicate device ishigher, this is not theactual fluence used intreatment (see nextrow)
Maximum fluenceactually used (as pertreatment protocols)	40J/cm2	43 J/cm2	Different. Thefluence of the EnekaPro is marginallylower than thepredicate but
			functionally they are
			the same
Frequency	1-4Hz (Dynamic)5-10Hz (FastDynamic)	UP TO 3 Hz (static)5 - 10 Hz (dynamic)	Same. The overallfrequency range ofthe two devices arethe same.
Pulse Duration	5ms-400ms	3 - 400 ms/ AUTO (3 ms)	Different. Thepredicate's low endpulse duration ismarginally higherthan the Eneka Probut it does not impacttreatment.
Treatment Mode	Dynamic and FastDynamic	Static and Dynamic	Same. The Eneka Pro'sDynamic modefunctions the same asthe predicate's Staticmode, and the EnekaPro's Fast Dynamicmode function the sameas the predicate's staticmode. Details on theirfrequencies are in thetable below. Thedifference are only inmarketing terminology.
Tissue Cooling	Contact coolingsystem	Contact cooling system	Same.
Cooling Temperature	3 °C	5°C	Different.
User Interface	LCD Touchscreen	LCD Touchscreen	Same.
Pulsing Control	Finger Switch	Finger Switch	Same.
Configuration	Main unit andhandpiece	Main unit, handpiece,and foot control(optional)	Same
Laser Classification	IV	IV	Same.
Power Supply	115 V a.c 50/60 Hz	Single Phase, 100-240V, 50-60Hz	Different.
Dimension	620 mm x 430 mm x630 mm	1140 x 480 x 550 mm	Different.
Weight	32 Kg	75 Kg	Different.

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Performance Testing

Verification and validation activities were successfully completed and establish that the Eneka Pro performs as intended. Testing included the following:

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510(K) Summary Eneka Pro

IEC 60601-1:2005 (Third Edition) + A1:2012 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance

IEC 60601-1-2:2014 Medical electrical equipment, Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility Requirements and tests

IEC 60601-2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment

ISO 10993-1: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

Software verification and validation testing was conducted, and documentation provided in accordance with FDA's Guidance or the Content of Premarket Submissions for Software Contained in Medical Devices.

Clinical Evidence – N/A. No clinical studies were conducted as part of this submission.

Conclusion

The Eneka Pro and Primelase Diode Lasers are nearly identical in the specifications. They have small differences in the design that do not impact the safety or effectiveness of the subject device, but only impact the user experience. The two devices can be considered substantially equivalent.

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.